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Effectiveness and Safety of Early Intramuscular Botulinum Toxin Injections to Prevent Shoulder Deformity in Babies With Obstetrical Brachial Plexus Palsy

Study acronym: POPB-TOX
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary and study completion dates: Apr 2025 to Jun 2027v9
  2. 2 versions Re-verified since Dec 13, 2023, no change to tracked fieldsv7-v8
  3. Site contacts updated at 1 of 7 sitesv6
  4. Primary and study completion dates: Jun 2021 to Apr 2025
    • Study sites: 6 to 7
    v5
  5. Site details revised at 2 of 6 sitesv4
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Nov 2020 to Jun 2021
    • Start date changed from estimate of Sep 2017 to May 17, 2018
    • Study sites revised (6)
    v3
  2. Secondary endpoints: details revised at 4 of 5 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In children population with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies shows that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity. The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 11 months and 18 months), compared to the Sham group.
Trial Details
NCT Number NCT03198702
Lead Sponsor University Hospital, Brest
Conditions
(from sponsor)		 Obstetrical Brachial Plexus Palsy
Related terms Neonatal Brachial Plexus Palsy
Enrollment 62 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov